Adjustable gastric banding apparatus have provided an effective and substantially less invasive alternative to gastric bypass surgery and other conventional surgical weight loss procedures. Despite the positive outcomes of invasive weight loss procedures, such as gastric bypass surgery, it has been recognized that sustained weight loss can be achieved through a laparoscopically-placed gastric band, for example, the LAP-BAND® (Allergan, Inc., Irvine, Calif.) gastric band or the LAP-BAND AP® (Allergan, Inc., Irvine, Calif.) gastric band. Generally, gastric bands are placed about the cardia, or upper portion, of a patient's stomach forming a stoma that restricts food's passage into a lower portion of the stomach. When the stoma is of an appropriate size that is restricted by a gastric band, food held in the upper portion of the stomach may provide a feeling of satiety or fullness that discourages overeating. Unlike gastric bypass procedures, gastric band apparatus are reversible and require no permanent modification to the gastrointestinal tract. An example of a gastric banding system is disclosed in Roslin, et al., U.S. Patent Pub. No. 2006/0235448, the entire disclosure of which is incorporated herein by this specific reference.
Over time, a stoma created by a gastric band may need adjustment in order to maintain an appropriate size, which is neither too restrictive nor too passive. Accordingly, prior art gastric band systems provide a subcutaneous fluid access port (“access port”) connected to an expandable or inflatable portion of the gastric band. By adding fluid to or removing fluid from the inflatable portion by means of a hypodermic needle inserted into the access port, the effective size of the gastric band can be adjusted to provide a tighter or looser constriction.
Typically, the access port, and in particular, the tubing leading from the access port to a reservoir or the inflatable portion of the gastric band may be susceptible to a misdirected needle. That is, a misdirected needle may puncture the tubing and cause leaking of fluid out of the gastric banding system, which may eventually lead to reduced efficacy of the gastric band. In some scenarios, the entire gastric banding system may then need to be removed from the body or the physician may need to perform an operation to mend the punctured tube.
Exterior tubing shields have been used as one option to protect the tubing from puncturing from stray needles. However, tubing shields add bulk, which may in certain patients, reduce the biocompatibility of the tubing and/or reduce the comfort of the gastric banding system within the patient.
What is needed is an interior tubing protection system that can reduce the likelihood and/or severity of leaking while still maintaining the relatively less bulky tubing currently incorporated in gastric banding systems.